A Study of TAK-360 in Adults With Narcolepsy Type 1 (Narcolepsy With Cataplexy)
26 de junio de 2026 actualizado por: Takeda
A Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Safety, Tolerability, and Efficacy of TAK-360 for the Treatment of Narcolepsy With Cataplexy (Narcolepsy Type 1)
Narcolepsy is a sleep disorder that disrupts a person's regular sleep-wake cycle. It causes extreme sleepiness during the day (called excessive daytime sleepiness [EDS]), where a person may fall asleep without warning. Narcolepsy Type 1 (NT1) is a form of the condition in which people also have sudden, unexpected muscle weakness while staying conscious (called cataplexy).
The main aim of this study is to learn how safe TAK-360 is and how well adults with NT1 tolerate it. Adults who can participate in the study will have to stop taking their existing medicines for NT1 before study treatment starts. Participants may be randomly (by chance, like drawing names from a hat) assigned to get either TAK-360 or placebo during the treatment period. The placebo looks just like TAK-360 but does not have any medicine in it. After the treatment period, participants can be monitored for another 2 weeks. Participants can restart their usual NT1 treatment after study treatment ends.
The participants will have to visit the clinic multiple times during this study.
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Estimado)
92
Fase
- Fase 2
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Takeda Contact
- Número de teléfono: +1-877-825-3327
- Correo electrónico: medinfoUS@takeda.com
Ubicaciones de estudio
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New South Wales
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Macquarie Park, New South Wales, Australia, 2113
- Aún no reclutando
- Takeda Site 2
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Barcelona, España, 8036
- Aún no reclutando
- Takeda Site 11
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Madrid, España, 28043
- Aún no reclutando
- Takeda Site 10
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California
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Redwood City, California, Estados Unidos, 94063
- Aún no reclutando
- Takeda Site 12
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Florida
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Miami, Florida, Estados Unidos, 33176
- Reclutamiento
- Takeda Site 14
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Ohio
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Cincinnati, Ohio, Estados Unidos, 45245
- Reclutamiento
- Takeda Site 13
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Paris, Francia, 75013
- Aún no reclutando
- Takeda Site 7
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Montpelier
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Herault, Montpelier, Francia, 34000
- Aún no reclutando
- Takeda Site 6
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Emilia-Romagna
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Bologna, Emilia-Romagna, Italia, 40139
- Aún no reclutando
- Takeda Site 8
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Veneto
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Verona, Veneto, Italia, 37134
- Aún no reclutando
- Takeda Site 9
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Fukuoka
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Fukuoka, Fukuoka, Japón, 812-0025
- Reclutamiento
- Takeda Site 17
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Kumamoto
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Kumamoto, Kumamoto, Japón, 862-0954
- Reclutamiento
- Takeda Site 1
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Nagasaki
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Isahaya-shi, Nagasaki, Japón, 854-0081
- Reclutamiento
- Takeda Site 18
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Osaka
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Yodogawa-ku, Osaka-shi, Osaka, Japón, 532-0003
- Aún no reclutando
- Takeda Site 15
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Tokyo
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Shinjuku-ku, Tokyo, Japón, 162-0851
- Reclutamiento
- Takeda Site 16
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Beijing Municipality
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Beijing, Beijing Municipality, Porcelana, 100053
- Reclutamiento
- Takeda Site 4
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Guangdong
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Guangzhou, Guangdong, Porcelana, 510515
- Reclutamiento
- Takeda Site 3
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Henan
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Zhengzhou, Henan, Porcelana, 450003
- Reclutamiento
- Takeda Site 5
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
Key Inclusion Criteria:
- The participant has a body mass index within the range 18 to 40 kilograms per meter square (kg/m^2) (inclusive).
- The participant has an International Classification of Sleep Disorders, Third Edition (ICSD-3) or ICSD-3 Text Revision diagnosis of NT1.
Key Exclusion Criteria:
- The participant has a current medical disorder, other than narcolepsy with cataplexy, associated with excessive daytime sleepiness.
- The participant: (a) has a history of myocardial infarction; (b) has a history of clinically significant thyroid disease, coronary artery disease, cardiac rhythm abnormality or heart failure.
- The participant has a clinically significant history of head injury or head trauma.
- The participant has a history of epilepsy, seizure, or convulsion (except for a single febrile seizure in childhood).
- The participant has a history of cerebral ischemia, transient ischemic attack (<5 years from screening), intracranial aneurysm, or arteriovenous malformation.
- The participant has a history of cancer in the past 5 years (does not apply to participants with carcinoma in situ that has been resolved without further treatment or basal cell carcinoma; these participants may be included after approval by the medical monitor).
- The participant has a positive test result for hepatitis B surface antigen, hepatitis B core antibody, hepatitis C virus antibody, or human immunodeficiency virus (HIV) antibody/antigen at screening.
- The participant plans to participate in any other interventional trial while participating in TAK-360-2004 or has previously participated in another part in TAK-360-2004.
- The participant has a known hypersensitivity to any component of the formulation of TAK-360 or related compounds.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Triple
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Part A: TAK-360
Participants will receive TAK-360 tablets, orally.
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TAK-360 tablet
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Comparador de placebos: Part A: Placebo
Participants will receive TAK-360 matching placebo tablets, orally.
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TAK-360 matching placebo tablet
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Experimental: Part B: TAK-360
Participants will receive TAK-360 tablets, orally.
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TAK-360 tablet
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Comparador de placebos: Part B: Placebo
Participants will receive TAK-360 matching placebo tablets, orally.
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TAK-360 matching placebo tablet
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Experimental: Part C
Participants will receive TAK-360 tablets, orally.
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TAK-360 tablet
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Parts A, B and C: Number of Participants With at Least One Treatment-emergent Adverse Events (TEAEs)
Periodo de tiempo: Up to approximately 28 weeks
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An adverse event (AE) is any untoward medical occurrence in a clinical trial participant, temporally associated with the use of the trial intervention, whether or not the occurrence is considered related to the trial intervention.
A TEAE is defined as any event emerging or manifesting at or after the initiation of treatment with a study intervention or medicinal product or any existing event that worsens in either intensity or frequency following exposure to the study intervention or medicinal product.
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Up to approximately 28 weeks
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Parts A and B: Change from Baseline in Mean Sleep Latency From the Maintenance of Wakefulness Test (MWT) at Week 6
Periodo de tiempo: Baseline, Week 6
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The MWT evaluates a person's ability to remain awake under soporific conditions for a defined period of time.
Because there is no biological measure of wakefulness, wakefulness is measured indirectly by the inability or delayed tendency to fall asleep.
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Baseline, Week 6
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Parts A and B: Change from Baseline in Epworth Sleepiness Scale (ESS) Total Score at Week 6
Periodo de tiempo: Baseline, Week 6
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The ESS provides individuals with 8 different situations of daily life and asks them how likely they are to fall asleep in those situations (scored 0 to 3) and to try to imagine their likelihood of dozing even if they have not actually been in the identical situation; the scores are summed to give an overall score of 0 to 24.
Higher scores indicate stronger subjective daytime sleepiness, and scores below 10 are considered to be within the reference range.
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Baseline, Week 6
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Parts A and B: Weekly Cataplexy Rate (WCR) at Week 6
Periodo de tiempo: Week 6
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Week 6
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Director de estudio: Study Director, Takeda
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Enlaces Útiles
- Click here to ask Takeda's chatbot for comprehensive and easy-to-understand information about clinical trials - even across products and indications - in your local language.
- Click here for more information about this trial in easy-to-understand language, including a Plain Language Summary of the results if the trial has been completed.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
4 de junio de 2026
Finalización primaria (Estimado)
28 de noviembre de 2027
Finalización del estudio (Estimado)
28 de noviembre de 2027
Fechas de registro del estudio
Enviado por primera vez
2 de junio de 2026
Primero enviado que cumplió con los criterios de control de calidad
2 de junio de 2026
Publicado por primera vez (Actual)
8 de junio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
29 de junio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
26 de junio de 2026
Última verificación
1 de junio de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- TAK-360-2004
- 2025-522587-33-00 (Ctis)
- jRCT2031260186 (Otro identificador: jRCT)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan IPD
Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5).
These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
Criterios de acceso compartido de IPD
IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/.
For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
- CIF
- RSC
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Sí
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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